PMA P110035S035

Device: EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P110035
Supplement: S035
Product code: NIO
Decision date: 2017-02-03
Classification: Stent, Iliac
Generic name: STENT, ILIAC
Approval order statement: Approval for several process changes that include qualification of a new wetline, new final cleaning equipment, a new manufacturing data system, and qualification of unchanged equipment moved from the Plymouth facility to the Maple Grove facility.

Current openFDA PMA Record#

Device: EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P110035
Supplement: S035
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2017-02-03
Decision code: APPR
Date received: 2016-06-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for several process changes that include qualification of a new wetline, new final cleaning equipment, a new manufacturing data system, and qualification of unchanged equipment moved from the Plymouth facility to the Maple Grove facility.